Author: [AUTHOR] Published on 11/4/2022 5:00:00 AM

FDA Announces Continuation of the MIDD Paired Meeting Program Under PDUFA VII

On September 30, 2022, the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII) was formally authorized by Congress as part of the US Food and Drug Administration (FDA) Reauthorization Act of 2023 (FDARA). In PDUFA VII, the United States Food and Drug Administration (FDA) committed to advancing modern approaches to enhance the efficiency of the drug development and review processes, such as model-informed drug development (MIDD). The FDA will build on the success of the MIDD Paired Meeting Pilot Program by continuing to facilitate and integrate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources in drug development and regulatory review.

For sponsors participating in the MIDD paired meeting program, FDA will grant a pair of meetings to provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development and provide advice about how particular MIDD approaches can be used in a specific drug development program. For each meeting request granted as part of the paired meeting program, FDA will conduct an initial and follow-up meeting on the same drug development issues. These meetings will be conducted by the clinical pharmacology or biostatistical review components within the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) in partnership with clinical staff at the relevant center to ensure alignment with decision makers.

There are significant changes to the MIDD paired meeting program under PDUFA VII:

• FDA will select one to two eligible and appropriate proposals per quarter each year. Additional proposals that meet the eligibility criteria may be selected depending upon the availability of resources.
• FDA will accept requests to participate in the program on a quarterly basis through June 1, 2027. Quarterly submissions are now due on the first day of the appropriate month.
• The meeting background package for the initial meeting is now due 47 days prior to the meeting.
• The second MIDD meeting will occur within approximately 60 days from receiving the meeting background package.

Learn more about the FDA’s MIDD Paired Meeting Program at the following link: https://www.fda.gov/drugs/development-resources/model-informed-drug-development-paired-meeting-program.

Additional information regarding the MIDD Paired Meeting Program will be available in a forthcoming Federal Register Notice.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.